Purpose

In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous glucose production) and plasma glucose concentration in diabetic subjects. Researchers will examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • BMI = 25-35 kg/m^2
  • must be drug naïve and/or on a stable dose (more than 3 months) of metformin and/or sulfonylurea
  • HbA1c >7.0% and <10.0%
  • Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis.
  • Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

Exclusion Criteria

  • Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded
  • Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Byetta / Bydureon
Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc
  • Drug: Exenatide
    Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
    Other names:
    • Byetta, Bydureon
Active Comparator
Dapagliflozin
4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg
  • Drug: Dapagliflozin
    10mg
    Other names:
    • Farxiga
Active Comparator
Byetta/Bydureon plus Dapagliflozin
Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS Dapagliflozin: 4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg
  • Drug: Dapagliflozin
    10mg
    Other names:
    • Farxiga
  • Drug: Exenatide
    Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
    Other names:
    • Byetta, Bydureon
Placebo Comparator
Placebo
Placebo group (4 weeks and 12 weeks)
  • Drug: Placebo
    Placebo for Dapagliflozin

Recruiting Locations

University of Texas Health Science Center
San Antonio, Texas 78229
Contact:
Eugenio Cersosimo, MD
210-358-7200
cersosimo@uthscsa.edu

More Details

NCT ID
NCT02981069
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Eugenio Cersosimo, MD, PhD
210-358-7200
cersosimo@uthscsa.edu

Detailed Description

This study will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose concentration compared to each agent alone.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.